The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

3726–3750 of 88106

  • SevereFDA (Devices)·Z-1404-2026·2026-02-25

    Medline Burn Care Kits Recalled Over Sterilization Calibration Issues

    Medline is recalling 291 units of three burn care convenience kits due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.

    Product
    Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0511-2026·2026-02-25

    IKM Aluminum Saucepan Recalled Over Lead Contamination Risk

    Lotus Mom Corporation is recalling 56 units of the IKM Aluminum Saucepan 9" with Wooden Handle due to potential leachable lead contamination. The product was distributed in California and Colorado.

    Product
    IKM Aluminum Saucepan 9" with Wooden Handle. Sticker label: ALUMINIUM PAN 2 SIDE POUTED WOODEN HANDLE 9" UPC 7 023672 411878 US $ 17.99 Sticker label: IKM INDIAN KITCHEN MART
    Category
    Consumer Product
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1415-2026·2026-02-25

    Medline Recalls Surgical Convenience Kits Over Sterilization Calibration Issues

    Medline is recalling 12,418 units of various surgical convenience kits due to calibration issues with equipment used for sterilization and packaging, which may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0516-2026·2026-02-25

    Frozen Cooked Shrimp Recalled Over Cesium-137 Contamination Risk

    H & N Group Inc. is recalling frozen cooked medium shrimp due to potential contamination with Cesium-137 from manufacturing under insanitary conditions. The product was distributed to approximately 30 retail locations in the greater Houston and Gulf Coast areas.

    Product
    Frozen Cooked Medium Shrimp Peeled & Deveined, Tail Off-White Shrimp; 1 lbs retail plastic bag. UPC: 041220333035
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1397-2026·2026-02-25

    Medline Sterile Surgical Kits Recalled Over Sterilization Equipment Calibration

    Medline is recalling 4,757 units of convenience surgical kits distributed worldwide due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.

    Product
    Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 5) KIT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1387-2026·2026-02-25

    Medline Nerve Block Trays Recalled Over Sterilization Calibration Issues

    Medline is recalling 448 units of its BASIC NERVE BLOCK TRAY W/LINEN (Model PAIN0150C) due to calibration issues with sterilization and packaging equipment that could affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1414-2026·2026-02-25

    Medline Labor and Delivery Convenience Kits Recalled Over Sterilization Calibration

    Medline is recalling 27,320 labor and delivery convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1371-2026·2026-02-25

    Olympus Thunderbeat Surgical Device Recall Due to Adverse Events

    Olympus is recalling 9,542 Thunderbeat surgical devices worldwide due to continued reports of adverse events. The recall affects all lots of the TB-0545FCS model.

    Product
    Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1382-2026·2026-02-25

    Olympus Thunderbeat Surgical Device Recall Over Adverse Events

    Olympus is recalling 1,538 Thunderbeat 5 mm surgical devices worldwide due to continued reports of adverse events. The recall affects all units of Model No. TB-0510IC.

    Product
    Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1362-2026·2026-02-25

    Wilson-Cook Medical Recalls Teslatome Bipolar Sphincterotomes Over Current Path Risk

    Wilson-Cook Medical Inc. is recalling 153 Teslatome Bipolar Sphincterotomes due to a potential void in the material separating the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.

    Product
    Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If…
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1352-2026·2026-02-25

    Olympus High Flow Insufflation Unit Recalled Due to Software Algorithm Issue

    Olympus Corporation of the Americas is recalling the Olympus High Flow Insufflation Unit (Model UHI) because a software algorithm issue may cause overpressure events.

    Product
    Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1407-2026·2026-02-25

    Triple lumen insertion kits recalled over sterilization calibration issues

    Medline is recalling 15 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1396-2026·2026-02-25

    GI endoscopy kits recalled over sterilization equipment calibration issues

    Medline is recalling 23,238 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1391-2026·2026-02-25

    PICC line and code cart kits recalled over sterilization calibration issues

    Medline is recalling 5,346 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number: ACC010487; 5) PEDS PICC INSERTION…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1409-2026·2026-02-25

    Drape packs recalled over sterilization equipment calibration issues

    Medline is recalling 240 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1425-2026·2026-02-25

    Universal and shoulder packs recalled over sterilization calibration issues

    Medline is recalling 193,157 units of surgical packs because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2026·2026-02-25

    Spinal and hip kits recalled over sterilization equipment calibration issues

    Medline is recalling 117,907 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1410-2026·2026-02-25

    Admit kits recalled over sterilization equipment calibration issues

    Medline is recalling 1,070 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2026·2026-02-25

    Endoscopy and angiography kits recalled over sterilization calibration issues

    Medline is recalling 3,561 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2026·2026-02-25

    Catheter cutdown trays recalled over damage to the outer tray

    Bard Peripheral Vascular is recalling 14,935 Broviac 4.2 Fr single-lumen CV catheter cutdown trays because damage to the outer tray can potentially compromise the sterile barrier.

    Product
    Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1398-2026·2026-02-25

    Lithotomy packs recalled over sterilization equipment calibration issues

    Medline is recalling 808 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;
    Category
    Medical Device
    Distribution
    Distributed nationwide